BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15796975 · Received November 15, 2022

    Report

    Report Number
    3007111389-2022-00601
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 18, 2022
    Report Date
    December 1, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE THE ROOT CAUSE FOR THE LOWER THAN EXPECTED VITROS IPTH RESULTS. ORTHO'S INVESTIGATION HAS IDENTIFIED THE ROOT CAUSE OF THIS ISSUE STEMS FROM A RAW MATERIAL USED IN THE AFFECTED LOTS. A COMMUNICATION ((B)(4)) WAS SENT ON 17 NOVEMBER 2022 TO ALL CUSTOMERS WHO HAVE BEEN SHIPPED VITROS IPTH REAGENT PACK WITHIN THE PREVIOUS 12 MONTHS. THE COMMUNICATION INFORMED CUSTOMERS THAT WHEN PERFORMING PATIENT SAMPLE TESTING USING THE AFFECTED IPTH LOTS (1610, 1621, 1630, 1640, 1645, 1650, 1670), CUSTOMERS MAY EXPERIENCE AN AVERAGE NEGATIVE BIAS OF APPROXIMATELY -12%. IN ADDITION, A VARIABLE NEGATIVE SHIFT IN PERFORMANCE WAS ALSO CONFIRMED USING BIORAD LIQUICHECK/LYPHOCHECK SPECIALTY IMMUNOASSAY CONTROLS AND THERMO SCIENTIFIC MAS OMNI IMMUNE IMMUNOASSAY CONTROLS WHEN COMPARED TO THEIR PUBLISHED ASSIGNED VALUES. ORTHO HAS ASSIGNED NEW MEAN AND SD VALUES FOR AVAILABLE BIORAD AND THERMO FISHER CONTROL LOTS FOR USE SPECIFICALLY WITH THE AFFECTED LOTS LISTED IN THE COMMUNICATION. THE FDA WAS NOTIFIED OF THIS ISSUE ON 17 NOVEMBER 2022. PLEASE REFER TO REPORT #(B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID WAS PROCESSED USING VITROS IPTH REAGENT LOT 1645 WHEN TESTED ON THREE DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. HOWEVER, A VITROS IPTH PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT AS ACCEPTABLE RESULTS WERE OBTAINED FROM THE SAME QC FLUIDS USING ALTERNATE LOTS OF VITROS IPTH. AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE CUSTOMER GAVE NO INDICATION OF ANY INSTRUMENT MALFUNCTION AND ACCEPTABLE RESULTS WERE OBTAINED USING ALTERNATE VITROS IPTH REAGENT LOTS WITHOUT PERFORMING ANY ACTIONS TO THE THREE DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. ORTHO HAS INITIATED AN INVESTIGATION FOR LOWER THAN EXPECTED RESULTS OBTAINED FROM MULTIPLE VITROS IPTH REAGENT LOTS TESTED ON MULTIPLE VITROS INSTRUMENT PLATFORMS.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE THE ROOT CAUSE OF THE LOWER THAN EXPECTED VITROS IPTH RESULTS. IN ADDITION, THE IPTH ISSUE WAS REPORTED AS A CLASS II RECALL AND A COMMUNICATION WAS SENT TO CUSTOMERS. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID WAS PROCESSED USING VITROS IPTH REAGENT LOT: 1645 WHEN TESTED ON THREE DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. BIORAD LEVEL 1 LOT: 64940 RESULT OF 16.09, 15.55 AND 15.76 PG/ML VERSUS THE EXPECTED RESULT OF 23.30 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS IPTH RESULTS OBTAINED WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103525 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 6802892 1645 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown